Clinical trial to state the importance of Preventive panchakarma (basti vidhi) in prediabetics

Phase 2/3

Recruiting

• Conditions: Other specified diabetes mellituswith unspecified complications. Ayurveda Condition: PRAMEHAH,

• Registration Number: CTRI/2023/07/055312
• Lead Sponsor: Dr. Tirth Mihir Shah

Brief Summary

Study summary -

This clinical trial is a controlled trial for MD dessertation under MUHS University .

total duration of trial - 3 years



Title name - Study the effect of Panchtikta niruh basti in the management of sthool pramehi with

special reference to diabetes mellitus (type-2) - Randomised controlled trial.



Intervention group - Panchtikta Niruh basti (panchkarma chikitsa)

control group - lifestyle modification and Diet ( as per clinically proven proforma and charts)



Groups

Group A - Intervention ( panchtikta Niruh basti kram - 8 days \* 2 sittings ) + lifestyle modifications and Diet chart .

Group B -  Only  lifestyle modifications and Diet chart .



Duration -  Three months for each patient.



Name of student - Dr. Tirth Mihirbhai Shah



Name of Guide - Dr. Kalpana Gholap- Dhomse.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-08
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

• RECENTLY DIAGNOSED CASE OF TYPE -2 DM WITH 1.Blood Sugar Levels Fasting 100 mg/dl – 126 mg/dl AND/OR Blood Sugar Levels PostPrandial 140 mg/dl -199 mg/dl. 2.Glycosylated hemoglobin i.e. HbA1C.
• 5.7 – 6.4 3.BMI > 25 ( overweight) [19]] 4.Gender: Male & Female both 5.Age.
• 30 to 60 years.

Exclusion Criteria

• TYPE-1 Diabetes Mellitus (IDDM) or patients who are currently on Insulin or any Oral Hypoglycemic Agents.
• k/c/o ketoacidosis, diabetic coma, diabetic nephropathy , Uncontrolled Hypertension ,gangrene.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To asses hypoglycemic action of intervention group in Prediabetics by taking into consideration of these standard markers i.e.	1) BSL - FF AND PP ON | Baseline , 1 month and 3 months. | 2)HBA1C on baseline and after 3 MONTHS .
1.BSL-Fasting & Postprandial	1) BSL - FF AND PP ON | Baseline , 1 month and 3 months. | 2)HBA1C on baseline and after 3 MONTHS .
2. HBA1C	1) BSL - FF AND PP ON | Baseline , 1 month and 3 months. | 2)HBA1C on baseline and after 3 MONTHS .
2)Compare the effect of panchtikta Niruh basti along with lifestyle modifications and specific diet in prediabetics.	1) BSL - FF AND PP ON | Baseline , 1 month and 3 months. | 2)HBA1C on baseline and after 3 MONTHS .

Secondary Outcome Measures

Name	Time	Method
To assess the effect of Panchtikta Niruh Basti in improving BMI & Waist circumference .	DAY 0 AND DAY 90

Trial Locations

Locations (1)

YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL , KHARGHAR; 🇮🇳 Raigarh, MAHARASHTRA, India

YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL , KHARGHAR

🇮🇳Raigarh, MAHARASHTRA, India

Dr Tirth Mihir Shah

Principal investigator

8169197188

teerthshah1@gmail.com